510(k) · Cleared
ClearedMiraclebreath Tongue Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stellar Labs, Inc. · LCN Scraper, Tongue
Cleared on Sep 23, 1999 as substantially equivalent to K962941 (Deep Trading Corp., 1996) and 1 other predicate after a 79-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Sep 23, 1999
- Review
- 79 days
- Class
- Class I
- Product code
- LCN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961660 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK961660 Tongue CleanerJack Conrey · 1996
- 2 generations backK972644 Breath-SO-Fresh Tongue CleanerIntl. Dental Design Specialists, Inc. · 1997
- 1 generation backK983683 Unik Tongue CleanerUnik Products, Inc. · 1999
- This deviceK992270 Miraclebreath Tongue CleanerStellar Labs, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961660 | Tongue Cleaner | Jack Conrey | 1996 | — |
| −2 | K972644 | Breath-SO-Fresh Tongue Cleaner | Intl. Dental Design Specialists, Inc. | 1997 | — |
| −1 | K983683 | Unik Tongue Cleaner | Unik Products, Inc. | 1999 | — |
| 0 (this device) | K992270 | Miraclebreath Tongue Cleaner | Stellar Labs, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LCN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962941 | Oolitt Tongue Cleaner, Regular Low Ripple/Special High Ripple/Low Ripple Double/High &…Summary page 1…lan Pomeroy lli 941.926.7745 941.926.2512 Wednesday, June 30, 1999 MiracleBreath Tongue Cleaner Tongue Scraper/Tongue Cleaner Tongue Scraper "Oolitt Tongue Cleaner” (K962941) “Unik Tongue Cleaner" (K983683) 4. Description of Device The device is a natural polypropylene band. It is formed into a u-sh… | 1996 |
| * | K983683 | Unik Tongue CleanerSummary page 1…926.2512 Wednesday, June 30, 1999 MiracleBreath Tongue Cleaner Tongue Scraper/Tongue Cleaner Tongue Scraper "Oolitt Tongue Cleaner” (K962941) “Unik Tongue Cleaner" (K983683) 4. Description of Device The device is a natural polypropylene band. It is formed into a u-shape by holding each end with the… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K962941.
How does its category compare?
All LCN devicesLCN Scraper, Tongue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCN
FDA has decided no LCN device since 2007.
Median 510(k) review, days · LCN
Too few LCN 510(k)s in any year since 2007 to give a median.
Recalls per year · LCN
No recall names LCN since 2007.
Adverse event reports per year · LCN
1in 2024
MAUDE reports naming product code LCN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To remove plaque and food debris from the surface of the tongue and to help fight bad breath and promote oral hygiene.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992270: Miraclebreath Tongue Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992270
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026